Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases

Sponsor

Uppsala University (Other)

Overall Status

Completed

CT.gov ID

NCT05665257

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases.

The main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by Thabane et al 2010.

Participants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Metastases	Device: Inspiratory muscle training Device: Mini-PEP	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Preoperative Inspiratory Muscle Training for Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - a Feasibility Study

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Sep 1, 2020

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inspiratory muscle training Participants in the intervention group were using a handheld device, Powerbreathe K3, aiming at increasing inspiratory muscle strength by applying an inspiratory resistance. They were instructed to use it twice a day for at least 14 days. Starting load was based on the baseline assessment of the participant's inspiratory muscle strength and increased during the intervention period.	Device: Inspiratory muscle training
Sham Comparator: Mini-PEP Participants in the control arm were instructed to use a handheld PEP-device traditionally used to facilitate deep breathing. The PEP-device does not provide any inspiratory resistance and therefore, it was considered a sham treatment. The control group were also instructed to use the device twice a day for at least two weeks.	Device: Mini-PEP

Arm

Intervention/Treatment

Experimental: Inspiratory muscle training

Participants in the intervention group were using a handheld device, Powerbreathe K3, aiming at increasing inspiratory muscle strength by applying an inspiratory resistance. They were instructed to use it twice a day for at least 14 days. Starting load was based on the baseline assessment of the participant's inspiratory muscle strength and increased during the intervention period.

Device: Inspiratory muscle training

Sham Comparator: Mini-PEP

Participants in the control arm were instructed to use a handheld PEP-device traditionally used to facilitate deep breathing. The PEP-device does not provide any inspiratory resistance and therefore, it was considered a sham treatment. The control group were also instructed to use the device twice a day for at least two weeks.

Device: Mini-PEP

Outcome Measures

Primary Outcome Measures

Feasibility of preoperative inspiratory muscle training [The different outcome measures are assessed continuously during a period from inclusion until discharge from the hospital. This period varied in length (3 weeks-3 months) depending on when participants were scheduled for surgery.]
Feasibility will be assessed using two domains: process and scientific feasibility. These domains include several parts such as recruitment rates, time available for training, intervention adherence, patient acceptability, pre-and postoperative respiratory muscle and lung function assessments, reproducibility of assessments, preliminary treatment effect, incidence of PPCs, and adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Scheduled for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

Surgery scheduled less than two weeks from the date of inclusion
Inability to speak and understand Swedish

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Uppsala University

Investigators

Principal Investigator: Mikael Andersson, PhD, Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Uppsala University

ClinicalTrials.gov Identifier:

NCT05665257

Other Study ID Numbers:

Ethical approval no 2016/338

First Posted:

Dec 27, 2022

Last Update Posted:

Dec 27, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Dec 27, 2022